Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
RTECS: Ammonium, (9-(o-carboxyphenyl)-6-(diethylamino)-3H-xanthen-3-ylidene)diethyl-, chloride
Author:
unknown
Year:
1961
Bibliographic source:
RTECS number BP3675000 citing TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1-1959- Volume(issue)/page/year:3,696,1961

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: no information on the method
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
12 weeks
Frequency of treatment:
not specified
Doses / concentrations
Dose / conc.:
50 400 other: mg/kg/12W-C
No. of animals per sex per dose:
not specified
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Nutritional and Gross Metabolic - weight loss or decreased weight gain
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Liver - changes in liver weight
Kidney, Ureter, Bladder - changes in bladder weight
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
dose level: TDLo (Lowest published toxic dose)
Effect level:
ca. 50 400 other: mg/kg/12W-C
Based on:
test mat.
Sex:
not specified
Basis for effect level:
body weight and weight gain
organ weights and organ / body weight ratios

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
Basic violet 10 was administered by oral route to rats for 12 weeks.
Some effects were observed: changes in liver weight and bladder weight, weight loss or decreased weight gain.
The Lowest published toxic dose (TDLo) was 50400 mg/kg/12W-C.
No further information was provided.